Buccal (oromucosal) midazolam

Midazolam belongs to a group of medicines called benzodiazepines, which are used to treat a number of different conditions, including seizures.

If a seizure lasts for more than five minutes, it may be difficult to stop unless treatment is given. It is therefore important that rapid treatment is given to stop the seizures and therefore prevent status epilepticus.

Status epilepticus is a condition where a person has a seizure (convulsion or fit) or a series of seizures that last for 30 minutes or more, without a complete recovery of consciousness.

Midazolam is chemically related to diazepam, which is another medicine used to treat seizures.

How is it given?

The midazolam solution should be placed against the sides of the gums and cheek so that the medicine is absorbed directly into the bloodstream. This is known as the buccal or oromucosal route. If the medicine is swallowed accidentally, it might not work as quickly.

Buccal midazolam is available as:

  • Buccolam® contains Midazolam Hydrochloride 5mg in 1ml in pre-filled oral syringes of 2.5mg, 5mg, 7.5mg and 10mg.
  • Epistatus® contains Midazolam Maleate 10mg in 1ml. It is a preparation in a 5ml bottle with four oral syringes in the packaging. Epistatus® is also available as pre-filled oral syringes of 2.5mg, 5mg, 7.5mg and 10mg. This is an unlicensed product, available as a ‘special’.

It is important to remember which brand and dose your child uses.

Instructions for giving buccal midazolam

  • Your local medical team will train you how to prepare and give buccal midazolam.
  • Always check the dose and expiry date before use.
  • Give the medicine slowly to stop your child swallowing the medicine as this may cause them to choke.
  • If buccal midazolam does not control the seizure within five minutes, follow the advice given by your doctor or call 999 for an ambulance.
  • If you cannot give buccal midazolam for any reason, give first aid and call 999 for an ambulance.

Using Buccolam® pre-filled oral syringes or Epistatus® pre-filled oral syringes

Important safety note about the Buccolam® pre-filled oral syringes only

The pre-filled syringes under the brand name Buccolam® come with a red protective cap on the end of the syringe, which should be removed before giving a dose to your child. Removing the red protective cap should also remove the translucent tip-cap underneath it but occasionally they do not come off together.

If the tip-cap is still in place, it will stop the medicine coming out of the syringe and if you push the plunger harder, the tip-cap itself could fall off and land in your child’s mouth, where it poses a choking risk.

When you remove the red protective cap, always check that the tip-cap has been removed as well. If it has not come off inside the red protective cap, pull this off separately before giving the dose to your child.

  1. Check the dose and expiry date of the pre-filled syringe provided
  2. Remove the oral syringe from the packaging
  3. Place the syringe into the side of your child’s mouth, between the gums and teeth
  4. If possible, divide the dose so you give half into one cheek and the remaining half into the other cheek.
  5. Slowly push the plunger of the syringe down until the syringe is empty
  6. Watch for any breathing difficulties
  7. Confirm that the seizure has stopped
  8. Dispose of the syringe safely

Using Epistatus® buccal liquid (midazolam maleate 10mg/1ml) 5ml bottle

  1. You will need the following:
  • Bottle of Epistatus®
  • Oral syringe provided
  1. Check that the liquid is clear with no crystals visible. Discard if you can see crystals.
  2. Unscrew the bottle cap, keeping the bottle upright
  3. Insert a syringe into the centre of the stopper
  4. Turn the bottle upside down
  5. Pull the plunger of the syringe back slowly and then push back to prevent any air bubbles
  6. Pull the plunger back again slowly and draw up the prescribed amount of liquid
  7. Turn the bottle the right way up before removing the syringe
  8. Put the cap back on the bottle to stop spillages
  9. Place the syringe into the side of your child’s mouth, between the gums and teeth
  10. If possible, divide the dose so you give half into one cheek and the remaining half into the other cheek.
  11. Slowly push the plunger of the syringe down until the syringe is empty
  12. Watch for any breathing difficulties
  13. Confirm that the seizure has stopped
  14. Dispose of the syringe safely

What are the side effects?

  • Drowsiness and sedation – recovery is usually fast
  • Amnesia or short-term memory loss – your child may not remember having had a seizure
  • Breathing difficulties – your child is unlikely to have breathing difficulties if midazolam is given at the correct dosage. If breathing difficulties do develop, seek medical assistance.
  • Restlessness, agitation and disorientation – these can occur but are usually rare.

Important information

  • Give the medicine as prescribed by your doctor
  • If your child stops using midazolam or it passes its expiry date, please return it to your pharmacist. Do not flush it down the toilet or throw it away.
  • Keep midazolam in a safe place where children cannot see it or reach it.
  • Keep midazolam at room temperature (not in a fridge), away from bright light or direct sunlight and away from heat.
  • Always check you have enough medicine and remember to order a new prescription in plenty of time.
Compiled by: 
The Pharmacy department in collaboration with the Child and Family Information Group, GOSH.
Last review date: 
December 2017
Ref: 
2017F0755

Disclaimer

Please read this information sheet from GOSH alongside the patient information leaflet (PIL) provided by the manufacturer. If you do not have a copy of the manufacturer’s patient information leaflet please talk to your pharmacist. A few products do not have a marketing authorisation (licence) as a medicine and therefore there is no PIL.

For children in particular, there may be conflicts of information between the manufacturer’s patient information leaflet (PIL) and guidance provided by GOSH and other healthcare providers. For example, some manufacturers may recommend, in the patient information leaflet, that a medicine is not given to children aged under 12 years. In most cases, this is because the manufacturer will recruit adults to clinical trials in the first instance and therefore the initial marketing authorisation (licence) only covers adults and older children.  

For new medicines, the manufacturer then has to recruit children and newborns into trials (unless the medicine is not going to be used in children and newborns) and subsequently amend the PIL with the approved information. Older medicines may have been used effectively for many years in children without problems but the manufacturer has not been required to collect data and amend the licence. This does not mean that it is unsafe for children and young people to be prescribed such a medicine ‘off-licence/off-label’. However, if you are concerned about any conflicts of information, please discuss with your doctor, nurse or pharmacist.